Clinical trial · Interventional
Internet-based Physical Activities Randomized Controlled Trial in Mild/Moderate Depression Participants: SONRIE Project
Internet-based Physical Activities Randomized Controlled Trial in Patients With Mild/Moderate Depression: Effects on Psychological and Social Well-being: SONRIE Project
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this randomized controlled trial is to determine the effect of an intervention program with physical activity for 12 weeks on depression, social and emotional well-being and quality of life and health in adults with mild and moderate depression. The main questions it aims to answer are: 1. \- To determine the association of physical activity levels, sedentary behavior, sleep patterns, physical condition, diet, and general health status with mental and social well-being, and quality of life in a large sample of adult patients diagnosed with mild or moderate depression. 2. \- To examine the predictive capacity of physical activity, sedentary behaviors, and physical condition on mild and moderate depressive disorder. 3. \- To study the effect of a period without an intervention program with physical activity (8 weeks without exercise intervention) on the variables studied. 4. \- To examine the role of the endocannabinoid system on depression as well as its behavior after an intervention program of physical activity. Participants will be involved in a physical activity intervention program for 12 weeks. Researchers will compare intervention group and control group to see if an intervention program with physical activity for 12 weeks improve depression, social and emotional well-being and quality of life and health in adults with mild and moderate depression.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult ALL | Adult Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Depression | — | UNRESOLVED | — |
| Exercise | — | UNRESOLVED | — |
| Physical Fitness | — | UNRESOLVED | — |
| Psychological | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise and psychological intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Exercise group
- description
- Group where the participants realize an intervention based on exercise and psychology.
- interventionNames
- Behavioral: Exercise and psychological intervention
- type
- NO_INTERVENTION
- label
- Control
- description
- Group where the subjects do not realize the intervention.
Primary outcomes (54)
- measure
- Depression PRE
- timeFrame
- month 11-12
- description
- Beck Depression Scale is composed of 21 items that evaluate severity of depression through the assessment of clinical symptoms such as sadness, crying, loss of pleasure, feelings of failure and guilt, thoughts or wishes of suicide, pessimism, etc. That measurements will be measured before the intervention program.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 25 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Male and female participants between 25-65 years. * Mild and / or moderate depression diagnosed by Beck Scale. * Do not have other severe somatic or psychiatric disorders or other diseases that prevents physical activity. * To be able to communicate with any problem. * To be able to read and understand the main purpose of the study. * Informed consent: must be capable and willing to provide consent. Exclusion Criteria: * Major depression diagnosed. * Acute or terminal illness. * History of cerebral infarction, epilepsy, brain tumor. * Unstable cardiovascular disease, or other medical conditions. * Upper or lower extremity fracture in the past 3 months. * Severe visual or auditory problems. * Unwillingness to either complete the study requirements or to be randomized into control or training group. * To be a participant in another research study that may influence the present project.
References
Publications (14)
- BACKGROUNDRichter P, Werner J, Heerlein A, Kraus A, Sauer H. On the validity of the Beck Depression Inventory. A review. Psychopathology. 1998;31(3):160-8. doi: 10.1159/000066239. PMID 9636945
- BACKGROUNDBECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available. PMID 13688369
- BACKGROUNDSpielberger CD, Gorsuch RL, L. R. State-trait anxiety inventory. Palo Alto Consult. Psychol. Press 1-23 (1970)
- BACKGROUNDRyff, C. D. Happiness is everything, or is it? Explorations on the meaning of psychological well-being. J. Pers. Soc. Psychol. 57, 1069-1081 (1989)
- BACKGROUNDDiaz D, Rodriguez-Carvajal R, Blanco A, Moreno-Jimenez B, Gallardo I, Valle C, van Dierendonck D. [Spanish adaptation of the Psychological Well-Being Scales (PWBS)]. Psicothema. 2006 Aug;18(3):572-7. Spanish. PMID 17296089
- BACKGROUNDWare JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83. PMID 1593914
- BACKGROUNDVilagut G, Ferrer M, Rajmil L, Rebollo P, Permanyer-Miralda G, Quintana JM, Santed R, Valderas JM, Ribera A, Domingo-Salvany A, Alonso J. [The Spanish version of the Short Form 36 Health Survey: a decade of experience and new developments]. Gac Sanit. 2005 Mar-Apr;19(2):135-50. doi: 10.1157/13074369. Spanish. PMID 15860162
- BACKGROUNDPietrobelli A, Rubiano F, St-Onge MP, Heymsfield SB. New bioimpedance analysis system: improved phenotyping with whole-body analysis. Eur J Clin Nutr. 2004 Nov;58(11):1479-84. doi: 10.1038/sj.ejcn.1601993. PMID 15138459